Eleven Biotherapeutics Reports Third Quarter 2017 Financial Results
-- Phase 3 Enrollment on Track to Complete in Q1 2018 --
-- Topline 3-Month Data from Phase 3 Trial of Vicinium™ on Track for Mid-2018 --
-- Strengthened Balance Sheet with
“I am very pleased with our progress this quarter. In addition to
strengthening our balance sheet with a successful public offering in
November, we also made strong progress during this quarter on our Phase
3 clinical trial examining Vicinium™ in patients with non-muscle
invasive bladder cancer (NMIBC),” said Stephen Hurly, President and
Chief Executive Officer of
Third Quarter Results, Recent Business Highlights and Anticipated Upcoming Milestones:
Vicinium™ is a single protein anti-epithelial cell adhesion molecule
(anti-EpCAM) antibody fragment fused with Pseudomonas Exotoxin A (ETA)
that is designed to specifically target and deliver a potent anti-cancer
payload directly into tumor cells. Vicinium™ is currently in a Phase 3
registration clinical trial for the treatment of high-grade NMIBC in
subjects who have previously received two courses of Bacillus
Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. The
company also has a
- In September, the Company announced completion of the manufacturing of Vicinium™ necessary for the ongoing Phase 3 registration trial in patients with NMIBC, and the CRADA trial with the NCI.
- Completion of enrollment for the Phase 3 registration clinical trial of Vicinium™ is expected in the first quarter of 2018.
- Topline three-month data from the Phase 3 registration clinical trial of Vicinium™ is expected mid-2018 and topline twelve-month data is expected in the second quarter of 2019.
- Initiation of a Phase 1 trial of Vicinium™ and durvalumab through the NCI CRADA will collect immune response biomarker data in patients with NMIBC and is expected to commence in the fourth quarter of 2017, with initial biomarker data expected in the third quarter of 2018.
Corporate:
- In October, the Company announced the appointment of Richard F. Fitzgerald as Interim Chief Financial Officer, adding extensive capital raising and transaction execution experience to Eleven’s management team.
-
In November, the Company completed a public offering of 5,525,000
shares of its common stock, pre-funded warrants to purchase an
aggregate of 4,475,000 shares of common stock, and common warrants to
purchase up to an aggregate of 10,000,000 shares of common stock,
raising approximately
$8.0 million in gross proceeds and$7.0 million in net proceeds, after deducting underwriting discounts and commissions and estimated expenses payable by the Company.
TPT Pipeline:
Eleven’s pipeline includes additional locally delivered product candidates, as well as a systemic TPT platform.
- Proxinium™ is a single protein anti-EpCAM antibody fragment fused with ETA for the treatment of late-stage, EpCAM-expressing, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). In Phase 1 and 2 clinical trials, Proxinium™ demonstrated anti-tumor activity in both injected as well as un-injected tumors. The Company plans to evaluate Proxinium™ in a Phase 1/2a clinical trial in combination with a checkpoint inhibitor and is actively seeking partners for a combination program.
- VB6-845d is a systemically-administered TPT utilizing a proprietary, highly potent, de-immunized plant toxin, deBouganin, for the treatment of solid tumors. The Company plans to file an investigational new drug (IND) application for VB6-845d and initiate a Phase 1 trial, once funding or a partner is secured for this program.
The Company has deferred further development of Proxinium™ and VB6-84d in order to focus its efforts and resources on the advancement of its Phase 3 registration trial of Vicinium™. The Company is also exploring partnering and collaboration strategies to move these additional product candidates forward.
Third Quarter 2017 Financial Results:
- Cash Position: Cash and cash equivalents were
$11.3 million as ofSeptember 30, 2017 , compared to$25.3 million as ofDecember 31, 2016 . These amounts do not include the approximately$7.0 million of net proceeds from the Company’sNovember 2017 public offering. - Revenue: Eleven did not record any revenue for the three months
ended
September 30, 2017 , compared to revenue of$28.7 million for the same period in 2016. This decrease was due to revenue recognized in 2016 from the Company’s License Agreement withRoche . The next licensing milestone payment expected fromRoche , if any, will be triggered upon commencement of a Phase 2 clinical trial byRoche . - R&D Expenses: Research and development expenses were
$3.6 million for the three months endedSeptember 30, 2017 , compared to$2.8 million for the same period in 2016. This increase was primarily due to higher costs incurred for the Company’s ongoing Phase 3 clinical trial for NMIBC that were partially offset by the absence of costs associated with the product candidate licensed toRoche in 2016 and lower compensation related costs. - G&A Expenses: General and administrative expenses were
$1.6 million for the three months endedSeptember 30, 2017 , compared to$6.4 million for the same period in 2016. This decrease was driven primarily by a reduction in severance, retention and stock-based compensation and professional fees related to the Company’s 2016 review of strategic alternatives and the acquisition ofViventia Bio, Inc. - Net Loss: Net loss was
$9.1 million , or$0.37 per basic and diluted share, for the three months endedSeptember 30, 2017 , compared to net income of$19.5 million , or$0.95 per basic share and$0.91 per diluted share, for the same period in 2016. The change was primarily the result of revenue recognized in 2016 from the Company’s License Agreement withRoche . - Financial Guidance: Based on current operating plans, the
Company anticipates that cash at
September 30, 2017 , plus the net$7.0 million raised inNovember 2017 , will fund research and development programs and operations into mid-2018.
About
Cautionary Note on Forward-Looking Statements:
Any statements in this press release about future expectations, plans
and prospects for the Company, the Company’s strategy, future
operations, and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “target,” “potential,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: the occurrence of any event change or
other circumstances that could give rise to the termination of the
License Agreement (License Agreement) with
ELEVEN BIOTHERAPEUTICS, INC. | ||||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) | ||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||
2017 |
2016 |
2017 |
2016 |
|||||||||||||||||||
Total revenue | $ | - | $ | 28,650 | $ | 425 | $ | 29,156 | ||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Research and development | 3,619 | 2,754 | 9,402 | 10,684 | ||||||||||||||||||
General and administrative | 1,631 | 6,366 | 6,085 | 11,984 | ||||||||||||||||||
Loss from change in fair value of contingent consideration | 3,900 | - | 7,600 | - | ||||||||||||||||||
Total operating expenses | 9,150 | 9,120 | 23,087 | 22,668 | ||||||||||||||||||
(Loss) income from operations | (9,150) | 19,530 | (22,662) | 6,488 | ||||||||||||||||||
Other income (expense), net | 45 | (43) | 180 | (1,066) | ||||||||||||||||||
Net (loss) income and comprehensive (loss) income | $ | (9,105) | $ | 19,487 | $ | (22,482) | $ | 5,422 | ||||||||||||||
Net (loss) income per share —basic | $ | (0.37) | $ | 0.95 | $ | (0.91) | $ | 0.27 | ||||||||||||||
Weighted-average number of common shares used in net (loss) | ||||||||||||||||||||||
income per share —basic | 24,691 | 20,495 | 24,663 | 20,004 | ||||||||||||||||||
Net (loss) income per share —diluted | $ | (0.37) | $ | 0.91 | $ | (0.91) | $ | 0.26 | ||||||||||||||
Weighted-average number of common shares used in net (loss) | ||||||||||||||||||||||
income per share —diluted | 24,691 | 21,423 | 24,663 | 20,796 | ||||||||||||||||||
ELEVEN BIOTHERAPEUTICS, INC. | |||||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||||||
(unaudited) | |||||||||||||||
(in thousands) | |||||||||||||||
September 30, | December 31, | ||||||||||||||
2017 | 2016 | ||||||||||||||
Assets | |||||||||||||||
Current assets: | |||||||||||||||
Cash and cash equivalents | $ | 11,338 | $ | 25,342 | |||||||||||
Prepaid expenses and other current assets | 770 | 585 | |||||||||||||
Total current assets | 12,108 | 25,927 | |||||||||||||
Property and equipment, net | 585 | 796 | |||||||||||||
Restricted cash | 10 | 10 | |||||||||||||
Intangible assets | 46,400 | 60,500 | |||||||||||||
Goodwill | 13,064 | 16,864 | |||||||||||||
Other assets | 101 | - | |||||||||||||
Total assets | $ | 72,268 | $ | 104,097 | |||||||||||
Liabilities and stockholders' equity | |||||||||||||||
Current liabilities: | |||||||||||||||
Accounts payable | $ | 1,366 | $ | 1,667 | |||||||||||
Accrued expenses | 2,915 | 1,774 | |||||||||||||
Deferred revenue | - | 425 | |||||||||||||
Due to related party | 123 | 114 | |||||||||||||
Total current liabilities | 4,404 | 3,980 | |||||||||||||
Other liabilities | 170 | - | |||||||||||||
Warrant liability | - | 5 | |||||||||||||
Deferred tax liability | 12,528 | 16,335 | |||||||||||||
Contingent consideration | 38,100 | 45,100 | |||||||||||||
Stockholders' equity: | |||||||||||||||
Common stock | 25 | 25 | |||||||||||||
Additional paid-in capital | 162,825 | 161,963 | |||||||||||||
Accumulated deficit | (145,784) | (123,311) | |||||||||||||
Total stockholders' equity | 17,066 | 38,677 | |||||||||||||
Total liabilities and stockholders' equity | $ | 72,268 | $ | 104,097 | |||||||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20171120005359/en/
Source:
Stern Investor Relations, Inc.
Michael Schaffzin, 212-362-1200
michael@sternir.com